Reverse Remodeling Effects of CDR132L in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Cardiac Hypertrophy

• Status: Withdrawn
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study including approximately 130 randomized HF patients with heart failure with mildly reduced or preserved ejection fraction (LVEF ≥45%), to assess efficacy and safety of CDR132L on reverse remodeling. In this study, patients with HFpEF (EF ≥50%) or HFmrEF (LVEF 45-49%) will be included.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cardior Pharmaceuticals GmbH

Criteria

Main Inclusion Criteria:

1. Provision of signed informed consent prior to any study-specific procedures.

2. Male or female of non-childbearing potential patients age ≥40 and <85 years.

3. Documented diagnosis of symptomatic heart failure (NYHA class II-IV) at enrollment, and a medical history of typical symptoms/signs of heart failure ≥6 weeks before enrollment with at least intermittent need for diuretic treatment.

4. Ejection fraction ≥ 45% (determined by echocardiography at site laboratory)

5. Increased intraventricular wall thickness (≥11 mm for female and ≥12 mm for male patients by echocardiography at site laboratory)

6. NT-proBNP > 300 pg/ml (sinus rhythm); >900 pg/ml (atrial fibrillation at time of screening/inclusion or documented with the last 6 months)

7. BMI between 22 kg/m² and 45 kg/m².

Main Exclusion Criteria:

1. Hemoglobin A1C (A1C) ≥10.5%

2. eGFR <35 mL/min/1.73m²

3. Systolic blood pressure (BP) <90 mmHg on 2 consecutive measurements at 5-minute intervals, at Screening.

4. Systolic BP≥180 mmHg on 2 consecutive measurements at 5-minute intervals, at Screening.

5. Planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement.

6. Stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment.